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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017231
Receipt No. R000007884
Scientific Title Postoperative concurrent chemoradiotherapy with paclitaxel/carboplatin chemotherapy in patients with high risk early stage cervical cancer.
Date of disclosure of the study information 2015/04/22
Last modified on 2018/11/22

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Basic information
Public title Postoperative concurrent chemoradiotherapy with paclitaxel/carboplatin chemotherapy in patients with high risk early stage cervical cancer.
Acronym Postoperative CCRT using paclitaxel/carboplatin in patients with high risk early stage cervical cancer.
Scientific Title Postoperative concurrent chemoradiotherapy with paclitaxel/carboplatin chemotherapy in patients with high risk early stage cervical cancer.
Scientific Title:Acronym Postoperative CCRT using paclitaxel/carboplatin in patients with high risk early stage cervical cancer.
Region
Japan

Condition
Condition Uterine cervical cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To develop a novel postoperative adjuvant radiotherapy in paients with high-risk early-staeg cervical cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes The maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of weekly paclitaxel/carboplatin chemoradiotherapy in early stage cervix cancer.
Key secondary outcomes The efficacy of postoperative paclitaxel/carboplatin chemoradiotherapy in early stage cervix cancer.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Concurrent weekly carboplatin and paclitaxel combined with adjuvant radiotherapy
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
75 years-old >
Gender Female
Key inclusion criteria Early-stage cervical cancer patients with positive pelvic lymph nodes.
Key exclusion criteria Early-stage cervical cancer patients without pelvic lymph nodes metastasis.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadashi KImura
Organization Osaka University Hospital
Division name Dept of Obstetrics and Gynecology.
Zip code
Address 2-2 Yamadaoka, Suita, Osaka 565-0871
TEL 06-6879-3351
Email tadashi@gyne.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Seiji Mabuchi
Organization Osaka University Hospital
Division name Dept of Obstetrics and Gynecology.
Zip code
Address 2-2 Yamadaoka, Suita, Osaka 565-0871
TEL 06-6879-3351
Homepage URL
Email smabuchi@gyne.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Hospital. Dept of Obstetrics and Gynecology.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 22 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 04 Month 22 Day
Last modified on
2018 Year 11 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007884

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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